How To Understand The Safety Management Program

Transcription

1 ENVIRONMENT OF CARE INTERVIEW QUESTIONS The Survey Team Process The following questions relate to each of the "Environment of Care" sections listed below. The "EC" interview session will be scheduled as a three-part review which includes the discussion, observation and conclusion phases. Other questions may also occur at any time when the surveyors determine that tracer methodology sessions have uncovered EC issues related to the patient treatment process. During the scheduled interview session, staff who have responsibilities related to the "Environment of Care" should be present. Relevant policies, procedures, and written supporting documents that indicate compliance with the required standards must be available and well-organized so that they can be explained to the surveyor, if requested. During the discussion portion of the EC interview, also be prepared to describe how a risk assessment process is used and documented and how each EC program component (safety, security, hazardous materials, etc.) meets each of the risk cycle components Plan, Teach, Implement, Monitor, Respond and Improve. Finally, identify who will participate in the "EC" interview and who will be the primary and secondary spokespersons for each "EC" area (safety, security, etc.). This will minimize confusion during the actual interview sessions. The Assessment Questions Safety Management 1. Has a management plan been written using a consistent format, that describes all of the required processes to effectively manage the safety environment for patients, staff and visitors? (EC.1.10) 2. Have proactive risk assessments (example: FMEA s) been conducted and documented for safety-related issues that may impact the environment of care, but are not specifically defined in the standards? (EC.1.10) 3. Have the results of these risk assessments been used to modify the safety management program to minimize risks to patients, staff and visitors? 1

2 4. Is there an incident reporting system that documents incidents that may occur to patients, staff or visitors and also ensures that product recalls are reviewed and acted upon? (EC.1.10) 5. Is there a hazard surveillance program that reviews and documents the environment at least twice annually in patient care areas and annually in non-patient areas to identify unsafe hazards and practices in the environment? (EC.1.20) 6. Does the hazard surveillance program also include documented rounds for the satellite (off-site) outpatient clinics? (EC.1.20) 7. Are all EC -related policies reviewed and revised, as necessary, but at least every three years? (EC.1.10) 8. Is there an individual who has been appointed to oversee and coordinate the safety management program for the facility (safety officer) and does this individual have a letter signed by the Chief Executive Officer that permits intervention in the event of a situation that could threaten life or health or damage property? 9. Is there a policy that describes how the exterior grounds are maintained? (EC.1.10) 2

3 10. Does the organization have a written No Smoking policy and is it enforced for patients, staff and visitors? (EC.1.30) 11. Does the organization monitor compliance with the smoking policy and develop strategies to reduce violations to the policy? (EC.1.30) 12. Is there a required safety orientation and annual training program for all staff, including physicians and volunteers? Is there also a method to assess knowledge after the training has occurred? (HR.2.20) The Assessment Questions Security Management 1. Has a management plan been written using a consistent format, that describes all of the required processes to effectively manage security for patients, staff and visitors? (EC.2.10) 2. Has an individual or organization been identified by leadership, in writing, to coordinate the security management program? (EC.2.10) 3

4 3. Have proactive risk assessments been conducted and documented for security-related issues that may impact the environment of care, but are not specifically defined in the standards? (EC.2.10) 4. Have the results of these risk assessments been used to modify the security management program to minimize risks to patients, staff and visitors? 5. Is there a method in place to document and evaluate security issues and incidents that occur? (EC.2.10) 6. Does the organization have a policy that describes how patients, staff and visitors are identified? (EC.2.10) 7. Have security sensitive areas been evaluated and identified in a policy, do these areas have controlled access and have staff in those areas been trained relative to the possible dangers, especially in the pharmacy, emergency department and OB/Gyn areas? (EC.2.10) 8. Do written policies exist for the following issues: VIP s (patients and visitors), media relations, parking and civil disturbances? (EC.2.10) 4

5 9. Is access to the emergency department maintained at all times for emergency vehicles? (EC.2.10) 10.Has the organization identified and implemented emergency procedures related to the possibility of infant or pediatric abduction? The Assessment Questions Hazardous Materials 1. Has a management plan been written using a consistent format, that describes all of the required processes to effectively manage the safety environment for patients, staff and visitors? (EC.3.10) 2. Are there current policies that address the cradle-to-grave treatment of all types of hazardous materials (infectious medical waste and sharps, chemical, radioactive and chemotherapeutic) that are used in the organization? (EC.3.10) 3. Has a method been approved by the organization that is used to identify and classify hazardous materials, and to create an inventory list that is consistent with applicable local, regional and federal regulations, such as OSHA, the NRC and EPA? (EC.3.10) 4. Are hazardous materials stored in locked areas that are accessible to authorized staff only and are the storage areas approved for the materials? (EC.3.10) 5

6 5. Does a policy exist that clearly describes how hazardous waste spills are reported, cleaned up and documented? Are all staff trained to understand these procedures? (EC.3.10) 6. Is there a program in place to monitor personnel exposure to the following hazardous Vapors, as applicable: formalin, xylene, nitrous oxide, glutaraldehyde, ethylene oxide, methyl-methacrylate and collodion? (EC.3.10) 7. Has an individual been assigned to apply for and maintain required permits and licenses and to ensure that the required material safety data sheets are accurate and readily available to all staff? (EC.3.10) 8. Are manifest forms for chemical and infectious wastes checked to ensure that they are received on a timely basis? (EC.3.10) 9. Are all hazardous chemicals properly labeled, especially for those that are placed into a container that is not the original one? (EC.3.10) 10. Are hazardous materials and wastes effectively separated from other areas of the facility during storage and processing? 6

7 The Assessment Questions Emergency Management 1. Has a management plan been written using a consistent format, that describes all of the required processes for emergency management and how to implement the procedures, when appropriate? Has the plan been written with participation from medical staff and executive management? (EC.4.10) 2. Has a vulnerability analysis been performed and documented to determine which disasters are likely to occur and which one will have a significant impact on the organization? Has this analysis been reviewed and approved by the safety committee? Has the analysis been used to determine which procedures will be included in the disaster manual? (EC.4.10) 3. Has the organization established disaster priorities resulting from the hazard vulnerability analysis in conjunction with the community? Has the organization also discussed it s role with the community related to emergency management and created a command structure for disaster implementation that is consistent with the command structure used by the community? (EC.4.10) 4. Have the procedures for the four phases of emergency management (mitigation, preparedness, response and recovery) been included in the disaster manual for each priority emergency? Do they include a procedure for initiating the plan phases and do they specify who is responsible for the initiation? (EC.4.10) 7

8 5. Is an incident command system that is compatible with the community been written into the disaster manual? Does it include an organizational chart with identified hospital staff, job action sheets and a method to initiate the system? (EC.4.10) 6. Is there a practical total facility evacuation plan that has been written in the event that the facility must be evacuated? Does the plan include a discussion of the logistics involved, such as patient records, medications, equipment, staffing, transportation, and an identified alternate site(s)etc.? (EC.4.10) 7. Does the plan describe how internal staff and external authorities will be notified during an emergency, and how the staff will be assigned? (EC.4.10) 8. Does the plan also include for the management of discontinuation of patient services, support activities for staff and their families, logistics for critical supplies, security and media communication? (EC.4.10) 9. Is there a written process in place to identify care providers and other personnel during emergencies, such as volunteer physicians and nurses? (EC.4.10) 10.Have processes been put into place to share information with other healthcare providers regarding command structures, names and contact information of command staff, available resources and assets and methods to identify patients who are transported from different facilities? (EC.4.10) 8

9 11.Have failure plans and back-up procedures been written for the loss of utilities, including communication systems, electricity, water, fuel, medical gas and vacuum, heating and cooling, ventilation and sewer? (EC.4.10) 12.Is there a written plan with appropriate equipment to treat patients who have been Chemically, radioactively or biologically contaminated? (EC.4.10) 13.Is there also a written plan for the medical center and community to effectively respond to a terrorist action? Have appropriate staff been trained to respond to such an emergency? (EC.4.10) 14.Have at least two emergency disaster drills been simulated (or have been actual disasters) during the past 12 months, and have they been at least 4 to 8 months apart? Have the drills been documented and evaluated? Has at least one of the drills been an external disaster and community drill? (EC.4.20) 15.Has there been at least one emergency preparedness drill conducted and evaluated at each of the outpatient satellite business occupancy clinics during the past year? (EC.4.20) 9

10 The Assessment Questions Fire Prevention 1. Has a management plan been written using a consistent format, that describes all of the required processes to effectively manage fire safety for patients, staff and visitors? (EC.5.10) 2. Is there a written fire plan that describes emergency procedures in the event of a fire emergency? Does the plan include department-specific procedures for staff, independent physicians (LIP s) and volunteers who are at and away from the point of origin of a fire and for horizontal, vertical and total facility evacuation? (EC.5.10) 3. Have all of the fire alarm and extinguishing system components been tested and documented as required by the NFPA documents listed below? Are the results maintained in a manner that permits easy retrieval? (EC.5.40) Required Test Test Frequency Reference Supervisory signal devices Quarterly NFPA 72, current edition Valve tamper switches Semi-annually NFPA 72, current edition Detectors and alarms Annually NFPA 72, current edition Notification devices Annually NFPA 72, current edition Fire department notification Quarterly NFPA 72, current edition Fire pumps Weekly, no flow NFPA 25, current edition Water tank level alarms Semi-annually NFPA 25, current edition Level alarms (cold weather) Monthly NFPA 25, current edition Main drain riser tests Annually NFPA 25, current edition Fire department connections Quarterly NFPA 25, current edition Fire pumps Annually, discharge flow NFPA 25, current edition Automatic kitchen systems Semi-annually NFPA 25, current edition Gaseous exting. Systems Annually NFPA 25, current edition Portable extinguishers Monthly, annually NFPA 10, current edition Occupant hoses Install, 5 yrs; hydro, 3 yrs NFPA 1962, current edition Fire and smoke dampers Every 4 years NFPA 90A, current edition Smoke shut-down devices Annually NFPA 90A, current edition Sliding/ rolling fire doors Annually NFPA 80, current edition 10

11 4. Is there a policy that describes what is required for floor and wall covering fire listings and what is permitted regarding fire ratings for purchased furnishings? Is there a holiday decorations policy that clearly describes which decorations are permitted? (EC.5.10) 5. Is the Statement of Conditions document current and does it accurately reflect the compliance with the 2000 Life Safety Code for all required healthcare and ambulatory facilities? Have all of the required portions of the document been completed (BBI, compartmentation drawings, LSA, PFI? Have all of the deficiencies noted in the PFI document that was reviewed and signed by the surveyor been corrected within the obligated time frame? If not, has a delay request letter been sent to the Joint Commission for new date approval? (EC.5.20) Note: Failure to meet the PFI deadline requirements can result in CONDITIONAL ACCREDITATION. 6. Has a building maintenance program been implemented to determine whether the operational life safety items in the facilities (exit lights; fire, smoke and corridor doors; barrier penetrations, etc.) function as they are intended? Is the effectiveness of the program measured? (EC.5.20) Note: This is a voluntary requirement. 7. Do record drawings exist that accurately depict the facility smoke, fire and building compartmentation? (EC.5.20) 11

12 8. Have fire drills been conducted and documented on every shift, during every quarter for every building that is classified as either healthcare or ambulatory? Have drills been conducted and documented at least annually per shift for all business occupancies where patients are examined or treated? Were the drills evaluated for staff response and did the evaluation include the following required items: 1) use of fire alarm components; 2) audibility of alarms; 3) containment of smoke and fire; 4) preparation for horizontal or vertical evacuation; 5) use of extinguishing equipment, and; 6) other specific fire-response duties? (EC.5.30) 9. Is there a policy that describes how interim life safety measures are determined, evaluated, implemented and documented, when required? Are forms used to document the evaluation of the need for interim measures as well as which measures apply and whether the interim measures have been implemented as determined through an inspection process? (EC.5.50) Note: Failure to implement or document required interim life safety measures can result in CONDITIONAL ACCREDITATION! The Assessment Questions Medical Equipment 1. Has a management plan been written using a consistent format, that describes all of the required processes to effectively manage the safe and reliable operation of medical equipment? (EC.6.10) 2. Does a policy exist that describes the process used to select and acquire medical equipment? (EC.6.10) 3. Is there a criteria evaluation used to determine which patient medical equipment is 12

13 included in the management program? (EC.6.10) Note: If a criteria evaluation is not used, then all medical equipment must be included in the program. 4. Is there a process to aggregate, evaluate and take necessary action for all medical equipment hazard recalls and FDA reports that may be required under the SMDA act? (EC.6.10) 5. Are there procedures to report and document equipment-related incident reports that may occur? Do the procedures also include emergency actions such as equipment failure, and access to back-up equipment and repair services? (EC.6.10) 6. Are the clinical users of medical equipment able to easily determine, such as through the use of tags affixed to the equipment, when the devices have been tested and when they are due to be tested again? (HR.2.20) 7. Do the equipment maintainers (in-house biomedical technician staff and outside contractors and vendors who are not the OEM) have documented competency assessments performed on a periodic basis? (HR.3.10) 8. Does an accurate, aggregated inventory exist for all devices that are included in the medical equipment management program, regardless of ownership and test/ repair responsibilities? Does this inventory clearly indicate life support and non-life support equipment? (EC.6.20) 13

14 9. Is all equipment that is included in the medical equipment program tested for safety and performance prior to use? 10. Is routine, scheduled preventive maintenance performed on life support and non-life support equipment that is consistent with maintenance strategies that have been established based upon equipment risks, manufacturer recommendations and historical data and are the test results documented? Have preventive maintenance on-time completion rates been established for the life support and non-life support equipment? (EC.6.20) Note: It is expected that the PM completion rates for life support equipment will be at 100% and for the non-life support equipment at least 90%. 11.Are the results of sterilizer preventive maintenance and repairs maintained? (EC.6.20) 12.Are the results of dialysis chemical and biological water tests documented and reported to infection control and the safety committee, when required? (EC.6.20) The Assessment Questions Utility Systems 1. Has a management plan been written using a consistent format, that describes all of the required processes to effectively manage the safe, effective and reliable operation of utility systems? (EC.7.10) 14

15 2. Is there a criteria evaluation used to determine which utility systems are included in the management program? (EC.7.10) Note: If a criteria evaluation is not used, then all utility equipment and systems must be included in the program. 3. Have utility systems been designed and installed that meet the patient care and operational needs of the organization? (EC.7.10) 4. Are there written test procedures, that include acceptable parameters and test intervals, for all of the utility systems and equipment included in the program? (EC.7.10) 5. Are there written procedures that describe actions that are required when utility systems malfunction, that include clinical interventions, alternate utility sources, valve closure responsibility and methods to obtain repair services? (EC.7.10) 6. Are one-line diagrams provided for the utility systems and Is accurate labeling provided for the following: 1) medical gas and vacuum shut-off valves; 2) electrical breaker panels; 3) utility isolation and shut-off valves? (EC.7.10) 15

16 7. Is there a policy that describes methods to minimize the possibility of water-borne pathogens that includes the following sections: 1) an infection control risk assessment that identifies which areas of the medical center house patients with compromised immune system function; 2) operational actions that are taken to minimize the growth of water-borne pathogens, such as legionella (water temperature, chemical treatment, ion-transfer systems, elimination of dead water legs, aerosol removal, shower head replacement, etc.); 3) a description of remediation actions taken in the event that a case of hospital-acquired legionella is verified? Are the procedures as defined in the policy implemented? (EC.7.10) 8. Is there a policy that describes how air filtration, air exchange and pressure relationships are maintained and tested in the following areas: operating rooms, special procedure rooms, delivery rooms, negative isolation rooms, protective isolation rooms, clinical laboratories, pharmacies and sterile supply areas? Are these tests performed and documented on a periodic basis? (EC.1.7) 9. Are emergency power generators installed that meet the requirements of NFPA 99, 101 and 110 with regard to life safety and critical branch circuits? (EC.7.20) 10.Does an accurate, aggregated inventory exist for all devices that are included in the utility equipment management program, regardless of ownership and test/ repair responsibilities? (EC.7.30) 11.Is all critical equipment that is included in the utility management program tested for safety and performance prior to use? 16

17 12. Is routine, scheduled preventive maintenance performed on the critical components of life support utility systems that is consistent with maintenance strategies that have been established based upon equipment risks, manufacturer recommendations and historical data and are the test results documented? (EC.7.30) Note: Expected PM completion rates for the life support components is 100%. 13.Is routine, scheduled preventive maintenance performed on the critical components of infection control utility systems for high-risk patients that is consistent with maintenance strategies that have been established based upon equipment risks, manufacturer recommendations and historical data and are the test results documented? (EC.7.30) Note: Expected PM completion rates for the infection control components is 100%. 14. Is routine, scheduled preventive maintenance performed on critical components of non-life support utility systems that is included in the management program and is it consistent with maintenance strategies that have been established based upon equipment risks, manufacturer recommendations and historical data? Are the test results documented? (EC.7.30) Note: Expected PM completion rates for the non-life support components is 90%. 15.Are the generators visually inspected on a weekly basis and tested under loaded conditions monthly (20 to 40 days apart) for at least 30 minutes and under at least 30% of the nameplate load? Are the tests documented and do they include tests for every transfer switch each month? (EC.7.40) 16. Are battery-powered egress lights in the healthcare facilities and satellite outpatient 17

18 clinics tested monthly for 30 seconds and is an annual 1.5 hour discharge test performed and documented? (EC.7.40) Note: If annual discharge tests are not performed, are the batteries changed in each unit on an annual basis? 17. If a Level I UPS system is installed (malfunction may severely jeopardize the life and safety of occupants), is it maintained according to the requirements in NFPA 111, which requires a quarterly functional test and annual test at full load? (JCAHO requires the test at 60% of full load) (EC.7.40) 18. Is there a documented preventive maintenance program for the medical gas and vacuum systems used in the healthcare facilities? Does it include preventive maintenance for the system source valves, zone valves, outlets, alarms, pressure switches, flexible connectors and other identified components in accordance with the manufacturer recommendations and prudent engineering practice? (EC.7.50) 19. Is the medical gas and vacuum system tested when new systems are installed or when existing systems are modified or repaired to ensure that the connections, pressures and purity of the gases is acceptable? Is the purity of the piped medical gases, including oxygen, nitrous oxide and medical air verified on a periodic basis to ensure that it is in compliance with the USP and FDA requirements? (EC.7.50) 20.Do the utility system maintainers (in-house staff and outside contractors and vendors) have documented competency assessments performed on a periodic basis if they test or maintain utility systems that might impact the clinical environment? (HR.3.10) 18

19 The Assessment Questions Appropriate Environment 1. Are interior spaces for patients appropriate to their care and needs? Do they include closet and drawer space for their personal property? For care longer than 30 days, does the setting provide for socialization and does it accommodate special equipment, such as that required for rehabilitation? (EC.8.10) 2. Are areas used by the patients safe, clean, functional and comfortable, and provide for suitable lighting and ventilation? Are door locks and restraints that are used consistent with the patients needs, policies and applicable regulations? (EC.8.10) 3. Prior to new construction projects, are applicable local, state and federal guidelines and regulations used as a guide? Is a Pre-Construction Risk Assessment performed and documented? Does the assessment include an evaluation for the impact of infection control, noise, vibration, air quality, utility failures, emergencies and interim life safety measures on the physical and patient environment? (EC.8.30) The Assessment Questions Measurement and Improvement 1. Does the organization measure and report the following indicator data: (EC.9.10) a. patient injuries and property damage b. staff illness and injuries c. security incidents involving patients, staff or visitors d. hazardous material spills, exposures and incidents e. fire-safety-related problems, deficiencies, and failures f. equipment problems, failures and user errors g. utility systems problems, failures and user errors 19

20 2. Has an individual (safety officer) been appointed by the Chief Executive Officer of the medical center to monitor and evaluate the organization s environment of care and coordinate the following tasks: a. collect information about deficiencies and opportunities for improvement in the environment of care; b. collect information related to hazard recalls; c. prepare summaries of EC -related deficiencies, problems, failures and user errors; d. prepare summaries of performance improvement activities; e. participate in incident reporting, hazard surveillance and policy and procedure development. (EC.9.10) 3. Is there a process that is used to monitor on an ongoing basis risks that are encountered in the environment of care, and are the management plans evaluated annually and changed as required based upon these risk assessments? (EC.9.10) 4. Have effectiveness evaluations been written for each of the seven EC areas on at least an annual basis? Have they been approved by the safety committee and reported to top management and the governing body? Does each evaluation specifically discuss the Scope, Objectives, Performance and Effectiveness of each plan and performance element? (EC.9.10) 5. Are issues in the environment of care that impact patient safety reported to the patient safety representative and integrated into the patient safety program? Similarly, are patient safety issues that affect the environment of care communicated to the safety officer and safety committee? (EC.9.10) 20

21 6. Is there a multi-disciplinary committee (safety) that meets on a prescribed basis (at least every other month, unless otherwise determined by experience and approved by the committee), to review, discuss, analyze, resolve and document environment of care issues? (EC.9.20) 7. Does the committee membership include a chair (usually the administrative representative), the safety officer, representatives from each of the EC areas (safety, security, hazmat, etc.), clinical representative, support services representative and the following additional representatives, either as standing members or invited guests: performance improvement, infection control, patient safety, employee health, satellite clinics, risk manager, radiation safety officer and laser safety officer? (EC.9.20) 8. Has at least one non-regulatory, numerical, performance measure been selected for each of the seven EC areas? Have goals, benchmarks and thresholds, as applicable, been selected for comparative purposes? Are the measures aggregated and reported to the safety committee on an ongoing basis? (EC.9.20) 9. Has at least one performance improvement initiative that occurred during the previous year been presented to top management for further action? (EC.9.20, PI) 10.Are summaries of the safety committee actions reported to the executive leadership and ultimately the medical center governing body on a periodic (at least quarterly) basis? (EC.9.20, LD) 21

22 11. Are EC issues that impact patient safety and the clinical environment communicated to the patient safety representative and executive leadership, when applicable? (EC.9.20, LD) 12. Are measurements of regulatory requirements and performance improvement issues monitored by the safety committee and reported periodically to executive leadership and as applicable, the patient safety program? (EC.9.30, LD) 22

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